Actively Recruiting
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling in Adults with Colorectal Liver Metastases
Led by Erasmus Medical Center · Updated on 2026-01-06
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether circulating tumor-derived DNA (ctDNA) can be reliably detected in small blood samples collected through automated capillary sampling in adults aged 21 years and older with colorectal liver metastases (CRLM). The study aims to compare ctDNA levels in capillary blood to those in venous blood to assess if the less invasive capillary method provides accurate results. This observational study is sponsored by Erasmus Medical Center and focuses on the feasibility of using this new sampling technique for ctDNA analysis in colorectal cancer care. Participants will provide a small capillary blood sample collected using an automated TAP4 device and a venous blood sample collected in a 10 mL EDTA tube during the same visit. The venous blood serves as the reference standard for ctDNA measurement. This proof-of-concept study will enroll about 35 patients with progressive colorectal liver metastases to assess the technical feasibility and correlation of ctDNA detection between the two blood collection methods. During the study visit, participants will give both types of blood samples. Researchers will measure ctDNA levels in both samples to evaluate agreement and technical feasibility. The primary outcome is the ability to detect ctDNA in small capillary blood volumes, while secondary outcomes include the correlation of variant allele frequency (VAF) between capillary and venous blood. The study is expected to complete by November 2027.
CONDITIONS
Brief Title
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- History of histologically confirmed metastatic colorectal adenocarcinoma
- Currently diagnosed with progressive colorectal liver metastases
- Signed informed consent to participate
You will not qualify if you...
- Currently responding to chemotherapy treatment
- Illiteracy or insufficient proficiency in the Dutch language
- History of skin infection after venipuncture or intravenous line requiring antibiotics or hospitalization
- History of immunodeficiency or current use of immunosuppressants
- History of blood-borne diseases such as HIV, hepatitis, or viral hemorrhagic fever
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants provide blood samples using automated capillary blood sampling and venous blood collection for ctDNA analysis to assess feasibility.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Erasmus MC University Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
M
Mirthe Ubink, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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